Events

Recall of CS100I INTRA AORTIC BALLOON PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    86189
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Maquet/getinge has received a complaint involving a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail) maintenance code #3 and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. an electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. the lack of power prevents the coil from moving the plunger causing the valve not to open. this is recognized by the system as an electrical test failure code #58 upon powering on the iab. units distributed after december 11 2013 are not affected by the field correction.

Device

CS100I INTRA AORTIC BALLOON PUMP
  • Model / Serial
    Model Catalog: 0998-00-0446H53 (Lot serial: > 10 numbers contact mfg); Model Catalog: 0998-00-3013-XX (Lot serial: > 10 numbers contact mfg); Model Catalog: 0998-00-0479H62 (Lot serial: > 10 numbers contact mfg); Model Catalog: 0998-00-3023-XX (Lot serial: > 10 numbers contact mfg)
  • Product Description
    CS100I INTRA AORTIC BALLOON PUMP;CS100 INTRA AORTIC BALLOON PUMP;CS300 INTRA AORTIC BALLOON PUMP
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC